Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism – the J-EINSTEIN DVT and PE program

Thrombosis Journal

Mariko Kajikawa⁴  Kazuma Iekushi⁴  Yuki Miyamoto⁴  Junichi Onuma⁴  Masaharu Kato⁴  Anthonie WA Lensing³  Martin H Prins⁵  Hiroo Shikata⁶  Satoru Sakagami⁸  Hideaki Maeda²  Atsushi Hirayama¹  Norikazu Yamada⁷ 

[1] Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan;Division of Cardiovascular, Respiratory and general surgery, Nihon University School of Medicine, Tokyo, Japan;Bayer HealthCare Pharmaceuticals, Wuppertal, Germany;Bayer Yakuhin Ltd, Osaka, Japan;Maastricht University Medical Center, Maastricht, The Netherlands;Department of Cardiovascular Surgery, Kanazawa Medical University, Ishikawa, Japan;Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Mie 514-8507, Japan;Department of Cardiology, National Hospital Organization, Kanazawa Medical Center, Kanazawa, Japan

关键词: Warfarin;    Venous thromboembolism;    Unfractionated heparin;    Rivaroxaban;    Randomized trial;    Pulmonary embolism;    Japan;    Deep vein thrombosis;   

Others  :  1135340
DOI  :  10.1186/s12959-015-0035-3

 received in 2014-10-23, accepted in 2015-01-04,  发布年份 2015

【 摘 要 】

Background

The global EINSTEIN DVT and PE studies compared rivaroxaban (15 mg twice daily for 3 weeks followed by 20 mg once daily) with enoxaparin/vitamin K antagonist therapy and demonstrated non-inferiority for efficacy and superiority for major bleeding. Owing to differences in targeted anticoagulant intensities in Japan, Japanese patients were not enrolled into the global studies. Instead, a separate study of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in Japanese patients was conducted, which compared the Japanese standard of care with a reduced dose of rivaroxaban.

Methods

We conducted an open-label, randomized trial that compared 3, 6, or 12 months of oral rivaroxaban alone (10 mg twice daily or 15 mg twice daily for 3 weeks followed by 15 mg once daily) with activated partial thromboplastin time-adjusted intravenous unfractionated heparin (UFH) followed by warfarin (target international normalized ratio 2.0; range 1.5–2.5) in patients with acute, objectively confirmed symptomatic DVT and/or PE. Patients were assessed for the occurrence of symptomatic recurrent venous thromboembolic events or asymptomatic deterioration and bleeding.

Results

Eighty-one patients were assigned to rivaroxaban and 19 patients to UFH/warfarin. Three patients were excluded because of serious non-compliance issues. The composite of symptomatic venous thromboembolic events or asymptomatic deterioration occurred in 1 (1.4%) rivaroxaban patient and in 1 (5.3%) UFH/warfarin patient (absolute risk difference, 3.9% [95% confidence interval, -3.4–23.8]). No major bleeding occurred during study treatment. Clinically relevant non-major bleeding occurred in 6 (7.8%) patients in the rivaroxaban group and 1 (5.3%) patient in the UFH/warfarin group.

Conclusions

The findings of this study in Japanese patients with acute DVT and/or PE suggest a similar efficacy and safety profile with rivaroxaban and control treatment, consistent with that of the worldwide EINSTEIN DVT and PE program.

Trial registration

Clinicaltrials.gov: NCT01516840 webcite and NCT01516814 webcite.

【 授权许可】

   
2015 Yamada et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

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